Tobacco Labeling and the Ethics of Persuasion

by Nadia N. Sawicki

The D.C. Circuit’s recent decision vacating the FDA’s graphic labeling requirements has prompted a flood of valuable commentary about compelled speech doctrine, including Richard Epstein’s, below.  While analysis of the First Amendment issues is important, I view the R.J. Reynolds case instead as an example of how emphasis on formal legal arguments may detract attention from the underlying source of public opposition.

My current research focuses on the state’s use of emotionally-gripping graphic imagery in medical and public health contexts. I focus on two examples – the “fear appeal,” exemplified by the FDA’s graphic tobacco labeling requirements; and appeals to positive emotions, such as maternal bonding, exemplified by state laws requiring that women view ultrasound images and hear the heartbeat of their own fetus before consenting to an abortion.

Both types of appeals to emotion have faced constitutional challenges – as violations of First Amendment compelled speech doctrine, or imposition of undue burdens on reproductive liberty interests.   But these formalistic constitutional tests do not, in my opinion, get at the heart of the public’s concern about government persuasion using emotional imagery.  Few contemporary commentators are willing to challenge requirements for scientifically valid textual warnings. Rather, it is the use of images – diseased lungs, cadavers, fetal heartbeats – that strikes a chord of concern among many critics.  Whether designed to inspire fear, love, or disgust, the government’s use of these images to persuade seems to run counter to the principles of democratic discourse.

Read More

Elderly drivers and fatal accidents: Is the doctor responsible?

[posted on behalf of Art Caplan]

Should a physician be held responsible if an elderly patient causes a car accident while driving?

A Los Angeles jury recently decided that Dr. Arthur Daigneault was not responsible for the wrongful death of 90-year-old William Powers, whose longtime partner, a dementia patient, drove into the path of an oncoming car, according to a report by The Los Angeles Times. The driver Lorraine Sullivan, 85, survived, but Powers died of his injuries weeks after the crash.

The Orange County, Calif. jury cleared Daigneault, but the case raises the question of whether the physician should have reported his patient — who had suffered memory loss since 2007 and was prescribed an Alzheimer’s drug in 2009 — to local health authorities or urged the California Department of Motor Vehicles revoke her license.

Read the rest over at NBC News Vitals.

The Body Snatchers: Human Recycling in The Global Age

By Michele Goodwin

For all the attention by legal scholars, doctors, and politicians to the global organ shortage—and particularly the crisis in the United States, relatively little is said about tissue demand and that supply industry.  Well known are the horrific stories involving black markets specializing in organs like kidneys and livers.  The troubling stories of Indian women, Pakistani men, and Brazilian boys pillaged for parts and left suffering with grotesque scars, owing debts, and in medical need are chronicled by a growing chorus of scholars (see here, here, and here).  Even those of us who support incentives to encourage organ donation strongly oppose human rights abuses paraded as free markets.  What scholars continually overlook, however, are the surreptitious, global tissue trades that effect more people and have the potential to cause greater harm, such as diseased tissues, bones, and other body parts entering the stream of US commerce and transplantation.

Several years ago, I presaged some of these problems and wrote about these issues; one of the articles can be found here.  More recently, an international consortium of journalist have come on board with an eye-opening special report, revealing black markets in Europe for human tissues and bones.  Their story begins in the Ukraine, where earlier this year security guards discovered body parts and skin stuffed into coolers, and envelopes filled with cash–transported on a “grimy white minibus.”  Authorities stumbled onto this body part heist thinking that a mass-murder had been uncovered. To their surprise, the bus and its contents were headed off to Germany before shipment of the parcels to Korea, the US and other countries.

On its own, tissue transplantation makes as much sense as organ transplantation, because they help to improve patients’ quality of life and in some instances may be vital to saving lives, such as heart valve transplants.  The problem is that the dark-side of this industry operates nefariously.  Sometimes this includes pillaging parts from cadavers dead from communicable diseases such as HIV and hepatitis or acquiring tissues through illegal means, or mislabeling parts—claiming that body parts are from Germany, when in fact they are from developing countries.  Often companies that trade on stock exchanges are linked to the darker side.  For example, investigators discovered that a US business, RTI, located in Florida is linked to the Ukraine discovery.  As Dr. Martin Zizi remarked to reporters, “once a [body part] is in the European Union, it can be shipped to the U.S. with few questions asked…They assume you’ve done the quality check, [but] we are more careful with fruit and vegetables than with body parts.”

Read More

Alan Wertheimer at HLS tonight

Short notice, but…

Alan Wertheimer will be presenting his draft paper “Why Is Consent a Requirement for Ethical Research?” tonight at the Health Law Policy and Bioethics Workshop at Harvard Law School.

These workshops take place on selected Mondays from 5-7pm, Hauser Hall, Room 105. This year’s schedule can be found here.  Open to the public – check it out if you’re in town.

Congratulations to Our Greenwall Scholar, Glenn Cohen!

The Greenwall Foundation has selected Bill of Health co-editor, Glenn Cohen, to receive a Faculty Scholar Award in Bioethics for 2012-2015. 

This career development award is intended to enable outstanding junior faculty members to carry out original research that will help resolve important policy and clinical dilemmas at the intersection of ethics and the life sciences.  Congrats, Glenn!

 

Research Participation as a Responsibility of Citizenship

by Suzanne M. Rivera, Ph.D.

For legitimate reasons, the human research enterprise frequently is regarded with suspicion.  Despite numerous rules in place to protect research participants’ rights and welfare, there is a perception that research is inherently exploitative and dangerous.

Consequently, most people don’t participate in research.  This is not only a fairness problem (few people undergo risk and inconvenience so many can benefit from the knowledge derived), but also a scientific problem, in that the results of studies based on a relatively homogeneous few may not be representative and applicable to the whole population. Larger numbers of participants would improve statistical significance, allowing us to answer important questions faster and more definitively.  And more heterogeneous subject populations would give us information about variations within and between groups (by age, gender, socio-economic status, ethnicity, etc.).

Put simply, it would be better for everyone if we had a culture that promoted research participation, whether active (like enrolling in a clinical trial) or passive (like allowing one’s data or specimens to be used for future studies), as an honorable duty.    (Of course, this presumes the research is done responsibly and in a manner consistent with ethical and scientific standards, and the law.) Read More

Is the USTR Trading Away Doctors’ Rights to Freely Perform Medical Procedures?

By Adriana Lee Benedict 

The 14th round of negotiations for the Trans-Pacific Partnership Agreement (TPPA, a multilateral trade agreement currently being negotiated by the USTR and 10 other countries) is currently underway in Leesburg, VA.  Last month, KEI posted a brief video blog about an interesting provision (Article 8.2) of the TTPA’s leaked draft IP chapter calling for patentability of diagnostic, therapeutic and surgical methods.  Critically, KEI pointed out that current US law (35 U.S.C. 287(c))—which was amended after widespread concern from physicians’ associations regarding the adverse public health effects of medical method patent liability were brought to light with Pallin v. Singer, 36 U.S.P.Q.2d (BNA) 1050 (D. Vt. 1995)—immunizes medical practitioners from patent infringement suits concerning medical methods, although the draft TPPA provision makes no such exception.  The proposed provision is also contrary to Article 27(3) of TRIPS and Article 1709(3)(a) of NAFTA, all of which allow countries to exclude such medical methods from patentability, as well as Rule 39.1 of the 1970 PCT, which exempts International Searching Authorities from having to conduct patent searches relating to medical methods.

Medical professional societies, including the WMA, AMA, AAOS, ACOG and ASRC, have also opposed medical procedure patents on ethical grounds.  The WMA has explained that patents are not necessary to incentivize innovation in medical procedures: “Unlike device development, which requires investment in engineers, production processes, and factories, development of medical procedures consists of physicians attaining and perfecting manual and intellectual skills… physicians already have both obligations to engage in these professional activities as well as rewards for doing so.”  The WMA has also noted a number of adverse effects on access to medical care resulting from medical procedure patents, including higher costs, fewer physicians available and/or willing to perform patented procedure, and less innovation in medical procedures.

So what does this mean for the TPPA negotiating parties? Read More

Discrimination in the Doctor-Patient Relationship

By Holly Fernandez Lynch

Nir Eyal’s post below has teed up the issue of doctors refusing to accept patients for reasons that seem to be pretty questionable.  The latest example has to do with obesity, but there are plenty of others having to do with vaccination status, sexual orientation, and the like.  Sometimes these refusals can be clearly categorized as conscientious objections (religious or otherwise).  And other times they are  a bit fuzzier, such as when the refusals are rooted in attempts to drive changes in behavior  (e.g., “get vaccinated or you can’t be my patient”) or when they stem from having inadequate staffing or equipment.  But for the patient, all of these refusals can feel discriminatory.   And that raises the obvious question: can doctors legally discriminate against patients?  The answer: it depends.  Sometimes yes, and sometimes no.

First, bear with me while I make the obligatory pitch for my book, Conflicts of Conscience in Health Care, which is now a few years old, but the issues are still very much live.  In that book, I delve deeply into the question of how to balance provider conscience and patient access.  In general, I argue that it is important to protect provider conscience, to a point (or points) – and those points have to do with burden on the patient and avoidance of invidious discrimination.   Read More

Broadening “Innovation Law & Policy” (and “Human Subjects Research”)

By Michelle Meyer

In legal scholarship and education, innovation law and policy is virtually synonymous with intellectual property in general, and with patent law in particular. This is curious and, I think, misguided. We expend considerable effort designing optimal incentives for innovation. We expend similar effort ensuring that socially useful knowledge, once produced, is widely and accurately disseminated. But if knowledge-producing activities themselves are suboptimally regulated, neither upstream incentives to engage in them nor downstream mechanisms to disseminate their fruits will much matter.

In Regulating the Production of Knowledge: Research Risk-Benefit Analysis and the Heterogeneity Problem, I

critically examine[] that regulatory framework, adopted by more than one dozen federal agencies in the U.S. and many other countries, which governs the vast majority of those knowledge-producing activities that have the greatest potential to affect human welfare: research involving human beings, or “human subjects research” (HSR). [The Article] focuses on the primary actors in the regulation of HSR — licensing committees called Institutional Review Boards (IRBs) which, before each study may proceed, must find that its risks to participants are “reasonable in relation to” its expected benefits for both participants and society. It argues for a particular interpretation of this risk-benefit standard and, drawing on scholarship in psychology, economics, neuroscience and other fields, argues that participant heterogeneity prevents IRBs from carrying out their regulatory duty. Instead, the regulatory system implicitly responds to the heterogeneity problem with risk aversion that is costly not only to researchers and society but, critically, to would-be research participants. The Article concludes by laying out the policy options that remain in the wake of the heterogeneity problem’s intractability: continuing the legal fiction of risk-benefit analysis, honestly embracing the heterogeneity problem and its costs, or jettisoning IRB risk-benefit analysis. A companion Article develops the possibility of the third option.

HSR is not, of course, unknown to the legal academy. Read More

No Doctor for the Obese?

by Nir Eyal

Yesterday, Boston public radio station WBUR interviewed a Massachusetts primary care physician who refuses to admit new obese patients. She claims that it’s because she lacks proper equipment, but she seems to have mixed motives. Earlier she had admitted that it’s rather because she feels that if they don’t lose the weight, “I’m paying the cost of other people’s choices.” I bet if she lacked the equipment for wheelchair-bound patients, she would go buy it.

In an upcoming post (09/07: update here), Holly Fernandez Lynch, who, along with Glenn Cohen, gets kudus for kicking off this blog, will explain whether it’s legal for doctors to reject obese patients. But before rejecting them becomes the next trend, is it right?

A whopping 35.7% of Americans are obese, and the trend continues upwards. Obesity increases risk for heart disease, stroke, type II diabetes, and various cancers. It costs the system a fortune. We must tackle this problem head on. But conditioning physician access on weight loss is not the way. Read More